U.S. patent application number 13/225989 was filed with the patent office on 2012-01-05 for medical devices with proximity detection.
This patent application is currently assigned to WELCH ALLYN, INC.. Invention is credited to Steven D. Baker, Braxton L. Lathrop, Soundharya Nagasubramanian.
Application Number | 20120003933 13/225989 |
Document ID | / |
Family ID | 47832499 |
Filed Date | 2012-01-05 |
United States Patent
Application |
20120003933 |
Kind Code |
A1 |
Baker; Steven D. ; et
al. |
January 5, 2012 |
MEDICAL DEVICES WITH PROXIMITY DETECTION
Abstract
A wireless medical device is disclosed. The wireless medical
device comprises a processor, a memory, a sensor for detecting a
physiological signal, a radio and a proximity detector to measure a
distance of the wireless medical device relative to a second
wireless medical device. The proximity detector includes a ranging
functionality. A wireless communication channel is created when a
distance between the wireless medical device and the second
wireless medical device is within a first predetermined threshold.
The distance is greater than zero.
Inventors: |
Baker; Steven D.;
(Beaverton, OR) ; Lathrop; Braxton L.; (Lake
Oswego, OR) ; Nagasubramanian; Soundharya; (Portland,
OR) |
Assignee: |
WELCH ALLYN, INC.
Skaneateles Falls
NY
|
Family ID: |
47832499 |
Appl. No.: |
13/225989 |
Filed: |
September 6, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12827817 |
Jun 30, 2010 |
|
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13225989 |
|
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Current U.S.
Class: |
455/41.2 |
Current CPC
Class: |
A61B 5/021 20130101;
H04W 4/029 20180201; A61B 5/318 20210101; H04W 4/023 20130101; A61B
5/0002 20130101; H04W 74/06 20130101; H04W 74/02 20130101; H04W
76/10 20180201; A61B 5/002 20130101; H04W 4/80 20180201; A61B
5/14542 20130101; H04W 4/02 20130101; A61B 5/01 20130101; G16H
40/40 20180101; H04L 67/14 20130101; G16H 10/60 20180101; H04W
76/38 20180201; H04W 76/30 20180201; H04W 76/18 20180201; G16H
40/67 20180101; H04W 76/14 20180201; A61B 5/0024 20130101 |
Class at
Publication: |
455/41.2 |
International
Class: |
H04W 88/00 20090101
H04W088/00 |
Claims
1. A wireless medical device, the wireless medical device
comprising: a processor; a memory; a sensor for detecting a
physiological signal; a radio; and a proximity detector to measure
a distance of the wireless medical device relative to a second
wireless medical device, the proximity detector including a ranging
functionality, wherein a wireless communication channel is created
when a distance between the wireless medical device and the second
wireless medical device is within a first predetermined threshold,
the distance being greater than zero.
2. The wireless medical device of claim 1, wherein the ranging
functionality is implemented using ultra-wide band technology.
3. The wireless medical device of claim 1, wherein the memory
stores a patient context, the patient context providing an
identifier for the patient, the patient context being obtained from
the second wireless medical device.
4. The wireless medical device of claim 3, wherein the patient
context is obtained from the second wireless medical device when
the distance between the wireless medical device and the second
wireless medical device is within the first predetermined
threshold.
5. The wireless medical device of claim 3, wherein the patient
context is obtained from the second wireless medical device upon
the detection of physiological signals by the wireless medical
device while within the first predetermined threshold.
6. The wireless medical device of claim 3, wherein the wireless
medical device transfers physiological data to a patient monitor,
the patient context being transferred along with the physiological
data.
7. The wireless medical device of claim 3, wherein the patient
context is removed from the wireless medical device based on
conditions determined by a clinical workflow definition for the
wireless medical device.
8. The wireless medical device of claim 3, wherein the patient
context is removed from the wireless medical device when a distance
between the wireless medical device and the second wireless medical
device is greater than a second predetermined threshold for at
least a predetermined time interval.
9. The wireless medical device of claim 3, wherein the patient
context is removed from the wireless medical device when a time
since a physiological measurement has been made at the wireless
medical device is greater than a predetermined time interval.
10. The wireless medical device of claim 1, the wireless medical
device further comprising a medical device identifier, the medical
device identifier providing a patient context for the patient.
11. The wireless medical device of claim 1, wherein the wireless
medical device is powered on when the distance between the wireless
medical device and the second wireless medical device is within a
pre-determined threshold.
12. The wireless medical device of claim 1, wherein the wireless
medical device creates or breaks a connection based on conditions
determined by a clinical workflow definition for the wireless
medical device.
13. The wireless medical device of claim 1, wherein the ranging
functionality is used to respond to queries.
14. The wireless medical device of claim 1, wherein the wireless
medical device changes state based upon a detection of motion of
the wireless medical device.
15. A method for authenticating a connection between two wireless
medical devices, the method comprising: moving a first wireless
medical device to the proximity of a second wireless medical
device; using a first proximity detector on the first wireless
medical device to determine a distance between the first wireless
medical device and the second wireless medical device; and allowing
authentication of a connection between the first wireless medical
device and the second wireless medical device when a distance
between the first wireless medical device and the second wireless
medical device is within a first predetermined threshold, the
distance being greater than zero.
16. The method of claim 15, wherein the distance between the first
wireless medical device and the second wireless medical device is
obtained using an ultra-wideband ranging capability of the first
wireless medical device and the second wireless medical device.
17. The method of claim 15, further comprising: when the connection
is authenticated, obtaining patient context information from the
second wireless medical device and storing the patient context
information on the first wireless medical device
18. The method of claim 17, wherein the patient context information
is removed from the first wireless medical device when the distance
between the first wireless medical device and the second wireless
medical device is greater than a second predetermined threshold and
when a time that the distance is greater than the second
predetermined threshold is greater is more than a predetermined
time interval.
19. A system for transmitting physiological data from a first
wireless medical device, the system comprising the first wireless
medical device and a patient monitor device, the first wireless
medical device comprising: a first processor; a first memory that
stores a patient context, the patient context providing an
identifier for the patient; and a first radio, the first radio
comprising a first ultra-wideband (UWB) transceiver that determines
a first distance between the first wireless medical device and the
patient monitor device, the first radio using the first distance as
part of an authentication process, the patient monitor device
comprising: a second processor; a second memory that stores the
patient context; and a second radio, the second radio comprising a
second UWB transceiver, wherein the first wireless medical device
joins a personal area network with the patient monitor device when
the first distance between the first wireless medical device and
the patient monitor device is within a first predetermined
threshold, the first distance being greater than zero, wherein the
first wireless medical device obtains the patient context from the
patient monitor device, the patient context being obtained from the
patient monitor device when the first distance between the first
wireless medical device and the patient monitor device is within
the first predetermined threshold for at least a first
predetermined interval of time, and wherein the first wireless
medical device transfers physiological data to the patient monitor,
the physiological data being transferred along with the patient
context, and wherein the patient context is removed from the first
wireless medical device when the first wireless medical device is
part of a spot workflow and when a second distance between the
first wireless medical device and the patient monitor device is
greater than a second predetermined threshold for at least a second
predetermined interval of time.
20. The system of claim 19, wherein the patient monitor presents a
confirmation request prior to storing the patient context when the
range to multiple patient monitors is within a pre-determined
threshold.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part application of,
and claims the priority and benefit to, U.S. patent application
Ser. No. 12/827,817, entitled "Body Area Network Body Improvements
for Clinical Workflows," filed Jun. 30, 2010, the entirety of which
is hereby incorporated by reference.
BACKGROUND
[0002] Personal area networks in a medical setting permit sensor
data from a patient to be efficiently transmitted to a display
device. Many such networks use Bluetooth technology both in sensors
attached to the patient and in the display device. Each Bluetooth
sensor is typically paired to the display device to enable the
transmission of sensor data to the display device.
[0003] In order for a Bluetooth sensor to be paired to a display
device, power must be applied to both the Bluetooth sensor,
including the sensor radio, and the display device including, the
display device radio. Each radio must be in a connectable mode.
Further, if the radios in the sensor and display device are not
aware of each other, at least one radio must also be in a
discoverable state. Typically, wireless sensors operate on battery
power. It is desirable that a mechanism for applying power to a
wireless sensor be easy to use, minimize drainage of the battery,
connect to the desired display device and ensure that the patient
be correctly identified.
[0004] In a medical setting, it is important that sensor devices
are correctly identified to ensure that the sensor devices are
placed on the correct patient. If the sensor devices are wired, the
patient identification is usually not an issue, since the wire is
run from the sensor directly to the monitoring device. However,
wireless sensor devices typically do not provide any patient
context, e.g., room number, patient ID, patient history, when
attached to a patient, so identification of the correct wireless
sensor devices with the correct monitoring devices can be an
issue.
SUMMARY
[0005] Aspects of the disclosure are directed to a wireless medical
device. The wireless medical device comprises a processor, a
memory, a sensor for detecting a physiological signal, a radio and
a proximity detector to measure a distance of the wireless medical
device relative to a second wireless medical device. The proximity
detector includes a ranging functionality. A wireless communication
channel is created when a distance between the wireless medical
device and the second wireless medical device is within a first
predetermined threshold. The distance is greater than zero.
[0006] In another aspect, a method is disclosed for authenticating
a connection between two wireless medical devices. A first wireless
medical device is moved to the proximity of a second wireless
medical device. A first proximity detector on the first wireless
medical device is used to determine a distance between the first
wireless medical device and the second wireless medical device.
Authentication of a connection between the first wireless medical
device and the second wireless medical device is allowed when a
distance between the first wireless medical device and the second
wireless medical device is within a first predetermined threshold.
The distance is greater than zero.
[0007] In another aspect, a system is disclosed for transmitting
physiological data from a first wireless medical device. The system
comprises the first wireless medical device and a patient monitor
device. The first wireless medical device comprises a first
processor, a first memory that stores a patient context and a first
radio. The patient context provides an identifier for the patient.
The first radio comprises a first ultra-wideband (UWB) transceiver
that determines a first distance between the first wireless medical
device and the patient monitor device. The first radio uses the
first distance as part of an authentication process. The patient
monitor device comprises a second processor, a second memory that
stores the patient context and a second radio. The second radio
comprises a second UWB transceiver. The first wireless medical
device joins a personal area network with the patient monitor
device when the first distance between the first wireless medical
device and the patient monitor device is within a first
predetermined threshold. The first distance is greater than zero.
The first wireless medical device obtains the patient context from
the patient monitor device. The patient context is obtained from
the patient monitor device when the first distance between the
first wireless medical device and the patient monitor device is
within the first predetermined threshold for at least a first
predetermined interval of time. The first wireless medical device
transfers physiological data to the patient monitor. The
physiological data is transferred along with the patient context.
The patient context is removed from the first wireless medical
device when the first wireless medical device is part of a spot
workflow and when a second distance between the first wireless
medical device and the patient monitor device is greater than a
second predetermined threshold for at least a second predetermined
interval of time.
[0008] The details of one or more techniques are set forth in the
accompanying drawings and the description below. Other features,
objects, and advantages of these techniques will be apparent from
the description, drawings, and claims.
DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 shows an example personal area network for a medical
application.
[0010] FIG. 2 shows example modules of a physiological sensor and
of the patient monitor of FIG. 1.
[0011] FIG. 3 shows an example patient monitor that includes a
proximity detector.
[0012] FIG. 4 shows example components of the proximity detector of
FIG. 3.
[0013] FIGS. 5 and 6 show a flowchart for a method of establishing
a connection between a sensor device and a gateway device in the
personal area network of FIG. 2.
[0014] FIG. 7 shows a flowchart for a method of transferring
patient context to a sensor device in the personal area network of
FIG. 2.
[0015] FIGS. 8 and 9 show a flowchart for a method of using
ultra-wideband ranging to establish a connection between a sensor
device and a gateway device in the personal area network of FIG.
2.
DETAILED DESCRIPTION
[0016] The present disclosure is directed to example systems and
methods for pairing physiological sensor devices for a patient in a
personal area network. Pairing is a term defined in the Bluetooth
Specification and it is used analogously herein, applying the
pairing concept to any radio. In the systems and methods, a
proximity detector is used to enable devices to execute functions
such as turning on power at a sensor device, turning on power to a
radio in the sensor device, and enabling the radio device to making
a radio connection between devices. Low-function proximity
detectors may only detect proximity. Medium function proximity
detectors may detect proximity and also transmit out-of-band data,
and may be used for authentication. High function proximity
detectors may also include ranging functions. The proximity
detector turns the power on at the sensor device when the sensor
device is in close proximity to a gateway device. The gateway
device is typically a monitoring and display device that also
provides access to a local or wide area network for transmitting
sensor data to a server computer. The gateway device also includes
a proximity detector. Typically, the gateway device includes a
source of AC power so that the gateway device is generally powered
on. However, in other examples, the gateway device may be battery
operated and may not be powered on until the gateway device comes
into proximity with a sensor device.
[0017] In example embodiments, the proximity detector on the sensor
device provides a magnetic mechanism to activate power at the
sensor device. Each proximity detector includes both a magnet and a
magnetic detector. When the proximity detector on the sensor device
is in close proximity with the proximity detector on the gateway
device, the magnetic detector on the gateway device detects the
magnet on the sensor device and the magnetic detector on the sensor
device detects the magnet on the gateway device. Such a device has
an advantage of very low power operation.
[0018] The detection of the magnet by the sensor device activates
power on the sensor device and the detection of the magnet on the
gateway device provides an indication to the gateway device that
power is activated on the sensor device. In examples where the
gateway device does not include AC power or in cases where the
gateway device does include AC power but is powered off, the
detection of the magnet on the gateway device activates power on
the gateway device. Once power is activated on both the sensor
device and the gateway device, a Bluetooth pairing sequence is
initiated and the sensor device is paired to the gateway
device.
[0019] If either the sensor device or the gateway device is already
powered, then the proximity detection may power the radio, enable
the radio and put the radio in a connectable state. If the radio in
either the sensor device or the gateway device is already powered,
then the proximity detection may put the radio in a connectable
state.
[0020] Other proximity detectors may be used. If each device has a
coil, magnetic coupling allows the coil in one device to detect if
the coil in the other device has a current. One could pulse current
in the first coil and detect the current pulse in the second coil.
Detection of the current pulse in the coil of the first device by
the coil of the second device would indicate proximity. A related
solution with a magnet and a coil in the first device and a
magnetic detector and a coil on the second device could have the
second device detect proximity of the first device through
actuation of the magnetic switch. The proximity detection causes
the second device to enable its radio and also to pulse a current
through its coil. This current pulse is detected in the first
device, causing it to enable its radio. Alternately, placing a load
on the receiving coil in the second device allows the transmitting
coil to detect proximity of the receiving coil as reflected
impedance of the receiving coil's load affects the current and
voltage in the transmitting coil. Modulating the load modulates the
current and voltage of the transmitting coil, allowing data to be
transmitted from the second device to the first device. Proximity
detection may be accomplished through time stamps of related
signals, such as acceleration when two devices are tapped together.
A time stamp on the signals can be used as a filter to ensure that
the two devices were tapped at close to the same time. Alternately,
a device may require a specific sequence such as three taps before
enabling the radio. Optical signals (IR, UV, or Visible) from one
device may be received by the second and these could be both
detected by the second device and be reflected back to the first
device. By encoding the optical signal, one may confidently assume
the signal is authentic. A resistive detection could be used to
detect if one device touches another as could one-wire serial where
making electrical contact causes one device to transmit data to the
other, where the data may include a Media Access Control (MAC)
address and other out of band communication such as a link key or
PIN. Capacitive touch switches may be placed on a printed circuit
board or embedded in the plastic cases creating a hidden switch
that is activated when a hand is brought nearby. Ultrasonic
transceivers, Ultra-Wideband (UWB) and RFID may be used for both
proximity detection and communication of out of band data. For
example, UWB can be used to determine if the range between two
radios is less than 25 cm and only then allow the radios to
connect. By only allowing the connection between devices at close
range, connections by devices external to the facility can be
prevented.
[0021] The term "out-of-band" refers to communications which occur
outside of a primary communication method or channel. In the UWB
example, if authentication is a function of range and ranging is a
secondary aspect of the UWB transceiver (the primary aspect being
transmission of data), then the ranging used for authentication is
an example of out-of-band communication. Using received signal
strength to infer relative distances between devices would be
considered an out-of-band communication of distance. Out-of-band
may also refer to using a second channel supported by a
transceiver. For example, standard data may be transmitted on a
first channel and high priority data may be transmitted on a second
channel. As a second example, data may be transmitted on a first
channel and descriptors such as patient ID or annotations for the
data may be transmitted on a second channel. As a third example,
BlueTooth might use 802.11 for authentication, there, 802.11 is the
out-of-band communication channel. The term "authentication" refers
to a process by which a first device is able to confirm the
identity of a second device and/or to confirm that the second
device should be trusted. Authentication may be unidirectional or
bidirectional.
[0022] The systems and methods of the present disclosure may also
use contextual data to determine when to change the radio state to
connectable or connectable and discoverable. For example, a sensor
may assume that it is in range of a gateway whenever the sensor is
powered, whenever a new measurement is requested or when other
contextual events occur and automatically put its radio in a
discoverable and connectable state. Other contextual events include
one or more of: losing connection to a previous gateway, detecting
a new gateway, detecting a decrease in received power from the
current gateway, detecting an increase in received power from a new
gateway, detecting a change in range to a gateway, and receiving
new patient information. Specific contextual events to be
considered depend on the clinical workflow, as discussed later
herein.
[0023] A personal area network is a computer network used for
communication between computer devices close to an individual
person. A personal area network may also be referred to as a body
area network when the personal area network is a collection of
physiological sensors and monitors. In this disclosure, pairing
refers to Bluetooth pairing and also to equivalent transmission of
credentials and information, such as an address, required to
establish a radio connection. These credentials may include
authentication credentials, such as public keys and nonces that may
be used to authenticate devices for secure, authenticated data
transfer.
[0024] In a medical setting, a personal area network may include
physiological sensor devices attached to a patient that are used to
monitor health parameters of the patient. Some examples of
physiological sensor devices used in a medical setting are blood
pressure monitoring devices, thermometers, ECG sensors, EEG
sensors, cardiac output sensors, ETCO.sub.2 sensors, oxygen
saturation sensors (SPO.sub.2), glucometers, weight scales, and
blood pressure sensors. Other types of sensor devices can be used.
The sensor devices typically transmit sensor data over a network to
a patient monitoring device, such as a wall-mounted display unit or
a central station, such as the ACUITY.RTM. Central Monitoring
System from Welch Allyn, Inc. of Skaneateles Falls, N.Y. A personal
area network may also include a smart phone such as an iPhone
manufactured by Apple Computer, Inc. of Cuppertino, Calif. or a
Personal Digital Assistant (PDA), perhaps used by a clinician to
interact with the patients' personal area networks such as the
Clinician Notifier product from Welch Allyn, Inc. of Skaneateles
Falls, N.Y. The PDA could join a patient network either using a
menu-based system as is common for Bluetooth connections today or
it could have a proximity detector that causes the PDA to join the
personal area network.
[0025] One type of radio device used in a wireless personal area
network is a Bluetooth radio. Bluetooth is a wireless technology
that can be used in personal area networks to transmit and receive
data over short distances (generally less than 30 feet, although
data can be transmitted up 100 meters depending on device class).
Bluetooth uses a layered protocol architecture consisting of four
core layers and associated protocols. The physical layer is the
lowest layer in each Bluetooth device and is instantiated as a
radio frequency ("RF") layer that includes a transceiver with
transmit and receive capability. Bluetooth uses the microwave radio
spectrum in the 2.402 GHz to 2.4835 GHz range.
[0026] Bluetooth devices are peer devices, each including a
Bluetooth radio and the four core protocol layers. However, when
two or more Bluetooth devices are connected in a personal area
network, one device can become a master device and the remaining
devices then become slave devices. A master Bluetooth device can
communicate with up to seven slave devices. However, a slave can
switch roles and become a master at any given time. A Bluetooth
device may be a slave in one personal area network and a master in
a second personal area network. Later version of the Bluetooth
specification, such as Bluetooth LE, provide for a larger set of
peer devices.
[0027] Because Bluetooth is a wireless technology, the integrity
and privacy of the transmitted data are a concern. To improve the
integrity and privacy of data transmission, Bluetooth permits two
devices to be paired with each other where the devices transmit on
an encrypted link so that they can securely communicate with each
other. Once two devices are paired, they can connect and
communicate with each other without additional user intervention.
The pairing process is typically initiated the first time a device
receives a connection request from a device to which it is not
already paired. During the discovery process Bluetooth addresses of
each device are shared and during the pairing process, a shared
secret key, known as a link key, is generated by the two devices.
This link key is used to generate an encryption key, which is used
to encrypt data for the current session. If the link key is stored
along with the Bluetooth address of the peer device, then the
devices are bonded so that the pairing information can be used in
the future, even if the device(s) has been power cycled or if the
devices have been out of range of each other. If either device
deletes the link key, pairing must occur again before communication
can occur. At the start of each communication session, the link key
is used in a process to cryptographically authenticate the identity
of the device, and be sure that it is the same device with which it
previously paired.
[0028] In a wireless personal area network, sensor data is
transmitted using a wireless data exchange protocol, such as
Bluetooth, to a central point, called a hub. Often, this central
point has a connection to a larger network, such as an 802.3 or
802.11 LAN. In this disclosure, a hub with a connection to a
different type of network is called a bridge or a gateway.
[0029] In a wireless personal area network for monitoring sensor
data, each sensor device may be joined to the network. In
Bluetooth, joining a network when none of the network information
is known requires discovery to learn the Bluetooth address of the
other device, connection to initiate communication, and pairing to
generate a shared secret key for authentication and encryption.
While this disclosure uses Bluetooth as an example personal area
network, any network, including 802.15.4, Bluetooth LE, ZigBee,
UWB, a low-power 802.11 network, Wi-Fi.TM. Direct, or a proprietary
network could be used. Other physical media such as IR as disclosed
in the IEEE 802.11-1999 standard and ultrasonic may be used in lieu
of RF. Of these, some technologies allow for ranging and ranging
allows proximity detection. These include at least UWB, IR, and
Ultrasound.
[0030] A hub to which multiple sensors are paired that includes a
display to show the physiological state of the patient is a patient
monitoring device. This type of hub typically has a local area
network uplink, making the patient monitoring device a bridge. Any
RF enabled device with a processor and display, including a PDA,
cellular phone, PC, or laptop can operate as a hub and also as a
patient monitor. The appropriate pairing of a sensor device with a
patient monitoring device ensures that the sensor data is properly
transmitted to the correct monitoring device. This is particularly
important in a medical setting that may include a plurality of
patients, sensors, monitoring devices and personal area networks to
ensure that a particular patient's physiological data is tagged
with the correct patient identifier. The patient identifier may be
encrypted independent of any encryption that occurs automatically
on the communication link to further ensure protection of
electronic personal health information.
[0031] The procedure for pairing a sensor device to a monitoring
device typically requires a user to manually enter data to
authenticate that the proper devices are connecting in order to
complete the pairing. For example, using Bluetooth 2.0, the two
devices that pair require that the same PIN is presented to both
devices. For some limited functionality devices, such as headsets,
the PIN for the headset may be hard coded into the headset and the
user enters the PIN into the device to be paired, e.g., a cellular
telephone. Since no data are transacted prior to PIN entry and the
PIN is not transmitted, this process verifies that the user intends
the two devices to establish a connection. This solution works
reasonably well if the device is only to be paired once. The PIN
solution also has security and usability issues, particularly as
implemented. For example, the PIN for most headsets is an easy to
remember number such as 0000 or 9999, so an intruder can guess the
PIN and masquerade as the intended device. In addition, a brute
force attack requires only 10,000 different sequences (Although
Bluetooth 2.0 uses a 16-byte PIN, this is usually generated by
augmenting a 4-digit PIN with part of the Bluetooth address of the
device, which is known). If the use case requires pairings to be
made, removed, and re-built as occurs in clinical applications, the
time to enter the PIN and navigate menus may be cumbersome. The
systems and methods described in the present disclosure permit
sensor devices to be attached to a patient and paired to a
monitoring device in an efficient and automated manner, thereby
minimizing the need for a user to manually enter information.
[0032] An improved pairing mechanism introduced in Bluetooth
Version 2.1+EDR is Secure Simple Pairing (SSP). SSP has four modes
of operation: Numeric Comparison, Passkey Entry, Out-Of-Band (00B),
and Just Works. With the first two modes, some degree of user
intervention is required to either enter or compare numeric values
that are computed as a function of the link key. In the third mode,
an auxiliary set of transceivers must exist to transmit the
Bluetooth pairing information. In the fourth mode, the devices
assume that a user authentication step occurred and opens the
device to a security risk, such as a man-in-the-middle (MITM)
attack. This risk can be mitigated by only placing the devices in a
pairing mode when proximity is detected and also through
application-level filtering of the devices. For example, if the
radios are neither connectable nor discoverable, except for a few
seconds while the pairing information is exchanged, it is extremely
unlikely an eavesdropper could detect the Personal Area Network
(PAN) and generate a MITM attack before the pairing completes. If
an incorrect device pairs, application level software can cause the
radio to delete pairing information and destroy the RF connection.
Such deletion and destruction can occur before any data are
accepted across the RF link. Application level software can
determine correct device pairings through several methods including
comparing the Bluetooth address to a known list of acceptable
addresses, through an application level challenge-response or other
authentication solution.
[0033] FIG. 1 shows example physiological sensors that can be used
on a patient 102 in a personal area network for a medical
application. The four physiological sensors include an example
thermometer 104, ECG sensor 106, blood pressure sensor 108 and
SPO.sub.2 sensor 110. The SPO.sub.2 sensor is also known as an
oxygen saturation sensor. The physiological sensors 104, 106, 108,
and 110 can be paired to patient monitor 208 and communicate with a
medical application over a personal area network, as described
below.
[0034] FIG. 2 shows an example personal area network 200 for a
medical application. The example personal area network 200 includes
the example SPO.sub.2 sensor 110 and an example patient monitor
208. The example personal area network 200 may also include one or
more of the example physiological sensors 104, 106 and 108 (shown
in FIG. 1). Each of the example physiological sensors 104, 106,
108, 110 has PAN capability. The example SPO.sub.2 sensor 110, as
well as the example sensors 104, 106 and 108, also includes a
proximity detector 202, sensor electronics 204 and a PAN radio 206.
The proximity detector 202 may be disposed within the radio 206.
For a Bluetooth radio, an approximate proximity detection may be
made using signal strength. For an UWB radio, absolute ranging may
be possible, allowing not just proximity detection, but also the
precise distance between two UWB radios.
[0035] The example patient monitor 208 includes a proximity
detector 210 and may include one or more embedded sensors 212 that
have a physical attachment to patient monitor 208. The patient
monitor also includes a display 214 that indicates the state of
various sensors and network connections. In addition, the patient
monitor 208 includes a PAN radio 216 and a LAN/WAN connection 218,
providing a gateway 217. The LAN/WAN connection 218 permits data to
be transmitted between the example personal area network 200 and
one or more server computers 220 that are accessible via the
LAN/WAN connection. Other network connections including mesh, UWB,
MAN and the like may allow connection to the one or more server
computers 220, patients sensors 210, or other patient monitors
201
[0036] Typically, the example physiological sensors 104, 106, 108,
110 are not powered on until they are activated and placed on the
patient. The example patient monitor 208 may be continually powered
on. For example, the patient monitor 208 may be wall-mounted unit
or may be permanently mounted to a stand or other apparatus in
hospital room. When the patient monitor 208 is permanently mounted,
the patient monitor 208 typically is connected to AC power and is
typically continually powered on. Alternatively, the patient
monitor 208 may be a portable unit that is operated via battery
power. When the patient monitor 208 is a portable unit, the patient
monitor is typically powered on manually via a power-on button.
However, in examples, a portable patient monitor may also be power
on automatically via the proximity detector 210.
[0037] Considering a Bluetooth PAN and other radios that have
similar connectivity solutions: in order for Bluetooth pairing to
occur, Bluetooth devices must be both discoverable and connectable.
By using a proximity detector in a Bluetooth device, for example
physiological sensor 110, the Bluetooth device may be kept in a low
power state to save power until the Bluetooth device is moved into
close proximity with a second Bluetooth device, for example patient
monitor 208.
[0038] In some examples described herein, the physiological sensor
110 is off. In other examples, the physiological sensor 110 can be
in a low power state including for example any of the following and
combinations thereof: the physiological sensor 110 being completely
off, the microprocessor of physiological sensor 110 operating in a
low power mode, the radio in physiological sensor 110 being in a
low power mode, the radio in physiological sensor 110 being on, but
not in a connectable state, or the radio in physiological sensor
110 being off. Regardless of the state of the physiological sensor
110 and its radio, detection of another proximal device causes the
physiological sensor 110 and its radio to move to a state where the
radio can connect to another device.
[0039] Starting from a state where physiological sensor 110 and
patient monitor 208 have never had a PAN connection, when the
physiological sensor 110 is moved proximally to the patient monitor
208, power is turned on at the physiological sensor 110, power is
turned on at the patient monitor 208 if power is not already turned
on at the patient monitor 208, the radios on both the physiological
sensor 110 and the patient monitor 208 are placed in connectable
mode and at least one radio is placed in discoverable mode, and
pairing occurs between the physiological sensor 110 and the patient
monitor 208. The pairing establishes a wireless connection between
the physiological sensor 110 and the patient monitor 208. Note that
if sensor 110 and patient monitor 208 have previously paired and
bonded, the radios do not need to discover each other. Similarly,
if the sensor 110 and patient monitor 208 have been provisioned
with the pairing information, perhaps at manufacturing, the radios
do not need to discover each other. Once paired to the patient
monitor 208, the physiological sensor 110 is placed on the patient
102 and physiological data is sent from the physiological sensor
110 to the patient monitor 208 via the wireless connection. For a
body-worn patient monitor 208, pairing may occur after the sensor
is placed on the patient 102 and pairing may occur after the
patient monitor 208 is placed on the patient 102.
[0040] Providing an auxiliary, low power discovery permits the
medical device to be selective in the devices with which it might
connect. For example, upon detection of an auxiliary discovery
signal, the radio may change state to "discoverable" or
"discoverable and connectable" for a limited time so that only the
opportunity to connect to the wrong device is decreased compared to
a device that is always in the "discoverable" or "discoverable and
connectable" state. If both sides of the connection have this
feature, then the opportunity to connect to the wrong device is
further diminished. When one device is AC powered, the radio may be
kept in connectable and discoverable mode all the time and rely on
the physiological sensor 110 to correctly initiate pairing.
However, if the device is always in a connectable and discoverable
state, the opportunity is open for either the wrong device or a
malevolent device to connect. Alternately, the AC powered device
may exit discoverable mode, but stay in connectable mode. This
allows another sensor, perhaps one that has lost contact with its
primary gateway, to send physiological data via an alternate
gateway. Even if this other sensor does not have a patient ID, a
unique identifier such as the sensor serial number can be
associated to the patient. With this unique identifier, sensor data
transmitted via an alternate gateway can be associated with the
correct patient ID at the server computer 220. Another case for
keeping radios in connectable mode allows re-connections to occur.
Once a physiological sensor is communicating with a patient
monitor, each will likely keep its radio in connectable mode, but
not discoverable mode. This allows the two devices to re-connect if
the RF link is broken, but does not allow any other devices to
discover the PAN. To keep the network more secure but still allow
devices to reconnect, the devices may also exit both discoverable
and connectable states after connecting to sensors and upon loss of
RF connection move to the connectable state.
[0041] As devices connect to different gateways, the status of
those devices, including location, need for periodic maintenance,
battery status, software revision and the like may be annotated to
a server for use by the biomedical engineers and clinicians. After
Bluetooth pairing is completed, status and configuration
information are transferred between sensor device and gateway
device, for example between physiological sensor 110 and patient
monitor 208, to verify that both the sensor device and the gateway
device are operational and compatible with each other. For example,
application software of patient monitor 208 may query physiological
sensor 110 to verify that physiological sensor 110 has passed a
diagnostics self-test, to verify the strength of a battery on
physiological sensor 110, to determine if any component of
physiological sensor 110 is in need of repair or due for periodic
maintenance, or to determine the status of the RF connection. This
status information may be transmitted along with other parameters
from the monitor such as its own RF connection strength to the IT
network, battery status, and location. These data may be used to
trend performance, debug connection issues, or to determine if
maintenance is required. In addition to the status information, the
sensor provides model and version information. The model and
version of the sensor device are compared with the model and
version of the gateway device to determine whether the sensor
device and gateway device are compatible.
[0042] When the sensor device and the gateway device are paired,
the sensor device and the gateway device are said to have a logical
connection with each other that is analogous to the connection that
occurs when a cable is plugged into the monitor. This logical
connection may occur at an RF level or at an application level. For
example, the logical connection may occur at the RF level after the
devices are paired or the logical connection may occur at the
application level when the compatibility check between devices is
completed. In the cable analogy, plugging the cable into the device
is analogous to the RF connection and the device recognizing the
cable and the sensors at the end of that cable are analogous to a
connection at the application level.
[0043] After status and compatibility are checked and verified
between sensor and gateway devices, a clinician may be required to
verify the sensor device for a specific patient requiring the
clinician to confirm the sensor device for a specific patient
provides an additional level of security to ensure that the sensor
device is placed on the correct person. In addition, the clinician
must confirm the sensor for a specific patient within a short time
period after the sensor device and the gateway device are placed in
connectable and discoverable modes. Through confirming the device
the clinician indicates to the system that the data from the new
sensor belongs to the same patient as is indicated on the patient
monitor. If the clinician does not confirm the sensor for a
specific patient within the short time period, the wireless
connection between the sensor device and the gateway device is
broken and the logical connection between the sensor device and the
gateway device is destroyed. The reset of the logical connection
might include removal of the pairing information. By allowing
pairing for only a short time period after the sensor device and
the gateway device are placed in connectable and discoverable
modes, MITM attacks are minimized. The time period must last long
enough for both radios to enter the connectable state and connect
or to enter the connectable and discoverable state, be discovered,
and connect. A short time period may be range from a hundred
milliseconds to several seconds. Preferably, the radio exits the
connectable state or the connectable and discoverable state
immediately upon initiation of a radio connection. Leaving the
logical connection in place could allow the sensor to maintain a
connection to the incorrect monitor. The system may be configured
to allow the unconfirmed connection to remain; but without
indicating the patient ID. In this case, a pseudo-ID may be used to
identify the data until such time as a patient ID is assigned to
the sensor. For example, the data might be saved in a database
keyed by the sensor serial number instead of the patient ID. If the
sensor is later correctly connected to the proper patient monitor,
the data that has been thus far collected and stored is annotated
with the patient ID associated with the proper patient monitor. In
a solution with proximity detection that supports ranging, the
system may have a set of rules that determine when the clinician is
required to confirm the sensor device for a specific patient. For
example, if a ranging solution has 25-cm range resolution and one
gateway is detected within a range of 1 meter and no other gateways
are detected within a range of 3 meters, it is likely that the
sensor is intended to connect to the gateway within a 1-meter
range. The rules may dictate cases where a clinical confirmation is
required, for example if two gateways are within a 1-meter range.
The rules may present to the clinician a list of gateways from
which to select for connection, based on range to the gateways.
This latter case provides the clinician a short list of likely
gateways (and hence patients) from which to choose.
[0044] After the clinician confirms the sensor device for a
specific patient, the clinician selects a connection mode for the
connection between the sensor device and the gateway. The
connection mode describes the extent to which alarms and equipment
alerts are generated in the connection. An alarm refers to an error
condition for a patient while an equipment alert refers to an error
condition for the medical equipment. Application software at the
gateway device permits the clinician to assign one of three
connection modes--loose pairing, tight pairing and locked. Each
connection mode is defined to match a specific workflow and
provides a class of alarm response. For example, loose pairing
provides one class of alarm response, tight pairing provides a
second class of alarm response and locked provides a third class of
alarm response. Other application-level connection modes and
combinations thereof may be used to match different workflows.
[0045] Loose pairing is typically used for a spot monitoring
workflow in which a sensor device is periodically brought into a
patient's room to check a physiological parameter that is not being
monitored by the patient monitor in the patient's room. This is
sometimes referred to as spot checking. In a workflow that uses
loose pairing, there are no equipment alerts if the connection
between the sensor device and the gateway device is broken. There
may also be no alarms as the workflow includes a clinician at the
patient location.
[0046] Tight pairing is typically used for a workflow in which
there is continuous monitoring of patient physiological data. In a
tight pairing connection, an equipment alert is generated whenever
certain error conditions occur. For example, an equipment alert is
generated when the wireless connection between the sensor device
and the gateway device is broken. This is analogous to an equipment
alert if an ECG cable is removed from the monitor or the ECG
electrode falls off the patient. Another error condition that
causes an alarm to be generated is when the gateway device
determines that one or more physiological parameters received from
the sensor device is above or below a predetermined threshold.
Other error conditions that cause an equipment alert condition to
be generated include: need for maintenance (including scheduled
periodic maintenance), sensor device loss of power, unacceptable RF
performance such as high packet loss or poor signal level, RF
interference, inappropriately sized blood pressure cuff detected,
ECG lead failure, SPO.sub.2 sensor with no signal detected, a
sensor that is not confirmed for a particular patient, and other
equipment alerts familiar to those skilled in the art.
[0047] When an error condition occurs in the tight pairing
connection mode where the connection from the patient to the device
comes into question, in addition to an alarm being generated, the
wireless connection between the sensor device and the gateway
device may be broken and pairing information for the connection may
be deleted at the sensor device and at the gateway device. For
example, if a physiological sensor falls of the patient, when the
physiological sensor is re-attached, the clinician may be required
again connect the Bluetooth radios. The deletion of pairing
information when the connection is broken prevents physiological
data from the sensor device from being associated with an erroneous
patient identification number. Alternately, the application level
software may allow the Bluetooth connection to persist, but stop
annotation of the data with the patient ID until the patient ID is
confirmed. A system may also stop the data flow from the sensor
until the patient ID is confirmed. Patient ID may be confirmed
through many means, including a clinician making a confirmation
step, absolute range to a gateway, absolute range to other
physiological sensors, or correlation of physiological signals. The
system may present a menu for the clinician to confirm the sensor
for the patient. The system may assume that if the range to the
gateway is less than a pre-determined threshold, the system may
confirm the sensor for the patient with no clinician action. The
pre-determined threshold is configurable to meet the needs of
various workflows. The system may have a record of the data and use
an algorithm such as pattern recognition to verify the sensor is
still attached to the same patient or the system may correlate the
physiological signal from the unconfirmed sensor with physiological
data from a confirmed sensor to determine if they are still on the
same patient. If the data correlates, the system may begin
annotating data from the previously unconfirmed sensor.
[0048] Locked pairing is used when it is determined that a sensor
device is only to be connected to a specific gateway device, for
example to the patient monitor 208 or to a select set of gateway
devices. A monitor on a roll stand with wireless sensors is an
application where locked pairing may be useful. When a sensor
device is used with locked pairing, an equipment theft alert is
generated when an attempt is made to connect the sensor device to a
gateway device that is not included in the select set of gateway
devices. The intent of a locked connection is to minimize the
potential for the sensor device from being moved, borrowed or
stolen from the gateway device to which the sensor device is
connected. To allow the locked sensor device to be moved to a
different gateway, as may be the case when the original gateway is
damaged or has a dead battery, a reset capability is designed into
the product. This may be through a hidden service screen, a reset
button, through a specific set of key strokes or similar method
that obscures the ability to remove the locked pairing
configuration.
[0049] The present disclosure is also directed to example systems
and methods for using a ranging feature of the proximity detector
to determine whether to add the sensor device to a PAN. Once a
sensor device is joined to a PAN and a gateway in the PAN has
patient context, the system may assume that all data from sensors
in the PAN is to be associated with the same patient. This gateway
is the patient's primary gateway. Data transmitted to the primary
gateway will be recorded in the patient's medical record. However,
in some cases it may be that sensors lose connection to the primary
gateway. The sensors may safely maintain the patient context while
continuously attached to the patient. This continuous attachment
can be determined if the sensor is continuously making a
physiological measurement, through a skin contact sensor, or
similar means. Sensors that lose connection to a primary gateway
may uplink data via an alternate gateway if the sensors have the
patient context, e.g. patient identifier, (PID) and transmit it
with the data via the alternate gateway or if the alternate gateway
has the patient context. For an alternate gateway to obtain the
patient context, the primary gateway may transmit the sensor's
unique ID, e.g., MAC address, and the patient context, e.g., PID,
to all other gateways in range. Then, the alternate gateway can
associate the physiological data received from the sensor with the
Patient ID: when a sensor joins an alternate gateway, the alternate
gateway associates the physiological data with the sensor's unique
ID and associates the sensor's unique ID to the patient ID. Another
way to support roaming is for all sensors to transmit a unique ID
with the patient data and have a system database that stores the
mapping between unique ID and patient ID. When a sensor joins a
primary gateway, the primary gateway receives the sensor's unique
ID and sends the sensor's unique ID along with the patient ID to
the system database. When a sensor moves to an alternate gateway,
the system may associate the patient ID to the received
physiological data based on the sensor's unique ID. This pseudo-PID
may be used if the system knows a unique serial numbered sensor is
associated with patient ID. In this case, the sensor can transmit
its serial number and the data via an alternate gateway and the
system can lookup the PID based on the serial number. In addition,
when the sensor device is added to the PAN, the systems and methods
provide for transferring patient context, typically in the form of
a patient identifier (patient ID), to the sensor device. Other
examples of patient context are a room number, clinician, date of
birth, gender, and patient history. Pseudo patient ID may also be
any unique number, e.g. a serial number or MAC address, when a
database maps that unique number to a patient identifiable datum
such as patient ID. Other examples of patient context and of pseudo
patient IDs are possible. In the case of using a pseudo patient ID,
the pseudo ID would be transmitted to the gateway after the sensor
joins the PAN, allowing the system to associate patient context via
the pseudo patient ID. The systems and methods provide for
transferring patient context from the sensor device along with any
physiological data that is transferred from the sensor device.
Transferring patient context along with physiological data helps
ensure that physiological data from the sensor device is correctly
identified, particularly in the case where the patient's sensors
are out of range of the patient's primary gateway (one that has the
patient context) and upload the data via a different gateway. In
some workflows, for example taking patient vitals in a triage
setting, there is no need to maintain patient context for a long
duration nor across multiple gateway and in these cases, patient
context may only exist in the primary gateway.
[0050] The ranging feature of the proximity detector makes uses of
UWB to determine the distance between the sensor device and other
devices with compatible UWB transceivers. For example, a sensor may
determine the distance between itself and a patient monitor on the
PAN with an UWB transceiver, for example patient monitor 208. The
sensor may also determine the distance between itself and at least
one other sensor with an UWB transceiver. Based on the distance
between the sensor device and the at least one other sensor device
or the distance between the sensor device and patient monitor 208,
a rules engine determines whether the sensor device may be added to
the PAN. Typically, the ranging feature provides for accurately
determining distances as close as 10 cm and continues to operate as
long as the two radios maintain a communication link. For a radio
operating in a PAN, this range is typically on order of 10 m, with
approximately 10 cm resolution. For radios operating with higher
signal to noise rations, the maximum range increases and ranging
resolution improves. The sensor device to be added to the PAN, for
example an SPO2 sensor, is typically brought into a hospital room
by a clinician. The SPO2 sensor typically sends out ranging signals
and the frequency of ranging signals may be traded off against
power consumption. Typically, a ranging response must be under 1
second or the user detects a lag in the system response. As a
result of exchanging ranging signals, the SPO2 sensor determines
the distance between the SPO2 sensor and the one other sensor
device or the distance between the SPO2 sensor and patient monitor
208. When the distance between the SPO2 sensor and the one other
sensor device or the distance between the SPO2 sensor and patient
monitor 208 is within a predetermined threshold, a determination is
made to add the SPO2 sensor to the PAN. The predetermined threshold
is stored on the SPO2 sensor and may be configurable. A typical
threshold is 25 cm, and other thresholds are possible. For example,
if a hospital ward has a standard room layout, the threshold may be
the distance from the door in the patient room to the patient
monitor 208 in that same room. When the SPO2 sensor is powered on,
the SPO2 sensor may immediately begin sending ranging signals. The
rate of sending ranging signals may change over time, for example,
high at turn on and high immediately after detecting another device
is within a range of perhaps 5-meters, but low at other times to
save power.
[0051] When it is determined that the SPO2 sensor is to be added to
the PAN, the SPO2 sensor is first identified and authenticated.
With a ranging technology such as UWB, a range requirement may be
implemented as part of authentication between sensor devices. The
system may be configured to transmit authentication information
over the primary channel when the range is within a certain value.
The system may be configured to require no authentication except
determination that the range is within a certain value. In this
case, ranging would be considered authentication using an OOB
channel. When the ranging occurs simultaneous to the data
transmission, a man-in-the-middle attack is mitigated as this sort
of attack would result in transmissions from a range that exceeds a
predetermined distance. The system may also be configured to use an
OOB channel for transmitting authentication credentials such as MAC
address and link key. Authenticating the SPO2 sensor (and other
sensor devices) when the SPO2 sensor distance is within the
predetermined threshold helps minimize MITM attacks.
[0052] Out-of-band communication may use one or several mechanisms,
for example, infrared, ultrasonic, magnetic, Wi-Fi, etc. As an
example of out-of-band authentication using a magnetic means, the
coil of the proximity detector in the SPO2 sensor may be used to
transmit the MAC address. The MAC address may be transmitted by
pulsing current through the coil in the SPO2 sensor on and off
thereby modulating the MAC address onto the current. The modulated
pulsed current from the SPO2 sensor is detected and demodulated by
a coil in the one other sensor device or gateway device already on
the PAN. Similarly, the two sides can generate and then share (or
compare) a link key across the OOB link. Various types of
modulation can be used, including amplitude modulation and phase
modulation. For example, amplitude modulation may be implemented by
varying the amount of current that is pulsed in the coil. A small
amount of current produces small pulses and a large amount of
current produces large pulses. Other methods of in-band and
out-of-band authentication are possible.
[0053] Once the SPO2 sensor is authenticated, a determination is
made as to whether the SPO2 sensor is to inherit the patient
context of the PAN. The determination is needed to ensure that
patient context is transmitted to the correct sensor device. It may
be that once range-based authentication occurs, patient context is
automatically communicated to the sensor device. Range-based
authentication may be either uni-directional or bi-directional. In
uni-directectional, range-based authentication, only one device
needs to determine whether it is within a pre-determined range
threshold. In bi-directional, range-based authentication, each
device measures the distance to the other and each device
determines whether it is within a pre-determined range threshold of
the other device before authentication is complete.
[0054] When making a determination as to whether another device
such as the SPO2 sensor is to inherit the patient context of the
PAN, several factors may be considered. One factor is the distance
between devices (for example the distance between the SPO2 sensor
and the one other sensor device on the body of the patient, already
part of the PAN). A second factor is a time interval that the
distance between devices is within the predetermined threshold. The
time interval is considered because devices may come into close
range for many reasons. For example, clinicians may have a sensor
device in their pocket at the time that the clinician comes in
close contact with the patient. The clinician may briefly come in
close enough contact with the patient that the sensor device in the
clinician's pocket may be within the predetermined threshold.
However, in this case the sensor device in the clinician's pocket
is not meant to join the PAN. However, if the clinician puts the
sensor device on the patient, it is a better indication that the
sensor device from the clinician's pocket is to be part of the PAN.
By considering the time interval that one sensor device is in close
proximity to another sensor device, a more accurate determination
can be made as to whether the sensor device should join the PAN. An
alternate solution is to allow the sensor to join the PAN with the
second factor of time interval set to 0. In this case, the sensor
would join the network, but when the clinician leaves the patient
proximity with the sensor, the rules engine removes the patient
information because it exceeded a predetermined range threshold
without ever have made a physiological measurement. A clinical use
case may indicate that a smart phone, PDA, tablet or similar device
the clinician carries is to join the PAN to learn the patient
context, allowing an application on the smart phone to
automatically call up germane forms, documents, or data for that
patient. For example, when a smart phone learns the patient ID, the
smart phone may automatically present a form for display and entry
of vital signs measurements when the user of the smart phone has
the role of recording vital sign measurements. Alternately, the
application might start an electronic health record (EHR)
application, such as Care360.TM. or AdvancedMD.TM.. When a sensor
on the PAN makes a reading and transmits it, the reading is
communicated to the EHR application, typically via an application
program interface (API). If the user of the smart phone has the
role of diagnosis (e.g., physician), then the application might
call a different view of the EHR or form, for example physical exam
notes, recent lab results, ECG or EEG waveforms, x-rays, or similar
relevant data. Since the smart phone likely doesn't have the
resolution to display an x-ray, the smart phone may work through
the network to discover a local display and cause the image to
display on that local display. These examples of using
proximity/ranging along with the clinical use case allow software
to present appropriate information to the caregiver.
[0055] A third example factor is whether the sensor device has made
a physiological measurement, particularly if the sensor device has
made a measurement within a range of a pre-determined threshold.
For example, if the sensor device is an SPO2 sensor and one or more
SPO2 readings have been taken from the sensor device, it is a good
indication that the sensor device should join the PAN for the
patient. Other example factors may be considered.
[0056] In examples, the rules engine determines whether a sensor
device is permitted to join a PAN and whether patient context is to
be transferred to the sensor device. The rules engine evaluates one
or more of the factors discussed in order to make this
determination. In addition, the rules engine may evaluate other
factors. The authentication step used to determine that patient
context is to be transferred to the new device, typically includes
use of an out-of-band channel, e.g., determining range. The patient
context may also be transmitted over an OOB channel. Even if
patient context is not transmitted to the sensor device, with the
sensor validated as a member of the PAN, the sensor can transmit
data to the patient monitor, where the data and patient ID are
associated. Data may be subsequently transmitted to the
EHR/EMR.
[0057] Transferring patient context to the sensor device via an OOB
channel is similar to authentication via the OOB channel. The
patient context comprises an identifier for the patient, typically
a Patient IDentification number (PID). The OOB channel may be a
magnetic channel, as discussed for authentication or it may be
another type of OOB channel, such as IR, ultrasound, wi-fi, using
an NFC standard, UWB, etc. In examples, once the sensor device is
authenticated and a determination is made to transfer patient
context to the sensor device, the patient context for the sensor
device is obtained from the patient monitor 208. The patient
monitor 208 typically stores patient context so that the patient
context can be displayed on a display screen of the patient monitor
208. In cases where the patient context is not stored on the
patient monitor 208, the patient monitor 208 may obtain the patient
context from the EMR/EHR system via gateway 218, from the ADT
(admit discharge transfer) system via gateway 218, or by clinician
entry of the information. Once the patient monitor 208 obtains the
patient context, the patient monitor 208 transfers the patient
context to the sensor device using either the OOB channel or
authenticated primary communication channel. The patient context is
then stored on the sensor device. Transferring patient context by
these means helps ensure that the personally identifiable
information (PII) is securely transmitted, particularly in the case
where a secure link on the primary channel cannot be created.
[0058] Some sensor devices, for example a thermometer, have limited
memory and are not able to store patient context information. When
a sensor device is unable to store patient context, a serial number
for the sensor device may be correlated with patient context. The
serial number in effect becomes a pseudo patient ID. In examples,
the serial number may be the global identifier sent to the patient
monitor 208 during the authentication process. When temperature
data is subsequently transmitted from the thermometer to the
patient monitor 208, the serial number is transmitted along with
the temperature data. When the patient monitor 208 receives the
temperature data and serial number, the patient monitor 208 looks
up the patient context from the serial number and identifies the
patient for which the temperature data is transmitted. Once the
patient context has been identified for the temperature data, the
patient monitor 208 is able to send the temperature data and the
patient context to the EMR/EHR system.
[0059] The radio on the sensor device typically is programmed with
a default configuration, including such parameters as the
predetermined threshold for ranging. The default configuration may
be updated in real-time without requiring a reset of the sensor
device.
[0060] The sensor device may determine ranging information based
solely on components included with the radio. Ultra-wide band
components are included in the sensor device. No add-on accessories
or software are needed as is the case in typical Wi-Fi location
solutions. Bluetooth and Wi-Fi solutions both lack the ability to
perform precise ranging.
[0061] The time duration for which patient context is stored on the
sensor device is dependent upon a clinical workflow. Different
workflows may be used for a patient in a medical setting. Some
example clinical workflows are continuous monitoring and spot
monitoring. Within these workflows, sensors may have monogamous and
polygamous connection profiles. Other example workflows may be
used. With a continuous workflow, sensor data is obtained from the
patient and transmitted to the patient monitor 208 on an ongoing
and continual basis. For a continuous workflow, patient context
remains stored on the sensor device even when the primary gateway
is not available. When the patient ambulates with the wireless
sensor devices, the wireless sensor devices can connect to any hub
or gateway to upload data. Because the wireless sensor has the
patient context, it can transmit the patient context with the data,
allowing the end receiver to unambiguously match the data with the
correct patient record. With a spot workflow, sensor data may be
obtained from the patient on a periodic basis, for example whenever
a clinician enters a room and takes vital signs for the patient.
With a spot workflow, sensor devices may be periodically added on
the body of a patient and periodically removed from a patient. When
a sensor device is permanently removed from a patient, any stored
patient context on the sensor device also needs to be removed from
the sensor device. With a monogamous connection profile the sensor
is provisioned to connect to exactly one other device. When the
sensor turns on, the sensor attempts to connect to only that one
device. This connection profile is useful when, for example, a
sensor is to stay in the same room and connect to the patient
monitor in that room. This profile is not agile, and once
provisioned, it is understood that the patient context of the
patient monitor and the patient context of the sensor will be the
same. When a new patient is brought to the room, the patient
context of the patient monitor is updated to match the new patient.
With a polygamous connection profile, the sensor is provisioned to
connect to any member of a set of other devices. For example all
thermometers on a hospital unit may be provisioned to connect to
any patient monitor deployed on that unit. The polygamous
connection profile is agile, but requires additional confirmation
steps such as a clinician's confirmation of a patient context
change or specific rules indicating the ranges at which a sensor
should abandon a first patient context and at which a sensor should
acquire a new patient context. The polygamous connection profile is
useful when, for example, a hospital unit has multiple sensor
devices such as thermometers and a clinician may use any
thermometer in any room. Here, the thermometer would require the
clinician to either enter the patient context, indicate which
patient monitor the thermometer should upload data to, or depend on
a rules engine with pre-determined ranges for breaking/ making
patient context changes. Using the rules engine, the thermometer
might connect to a monitor that is within a range of 1-m. If the
thermometer detects multiple monitors within approximately 1-m
range, for example 1.2 and 1 meter, then the rules engine may query
the clinician to confirm the monitor rather than making an
automatic confirmation. The ranges and rules are determined by the
clinical work flow and physical setup in a given environment.
During provisioning, the sensor device is programmed with the
clinical profile (including connection) parameters. For example, a
thermometer may be provisioned for spot monitoring and a polygamous
connection profile as follows: [0062] When the sensor device is
within 1 meter of a patient monitor and there is no current
connection to a monitor, the sensor device attempts to connect to
that patient monitor. [0063] Moving more than 5-m from the
connected monitor results in a disconnect and removal of any
existing PID. [0064] As long as no other patient monitor is within
the 1 meter range and the current monitor is within a 5 meter
range, the sensor device stays connected for 5 minutes, with the
connection timer reset each time a physiological measurement is
made. [0065] If another patient monitor is within the 1 meter
range, the current monitor is within the 5 meter range, and the
time has not expired, a request is annunciated to confirm a change
of patient monitor. [0066] When connecting to a new patient
monitor, the system associates the thermometer data with the
patient context of the new patient monitor.
[0067] With the polygamous connection profile, a clinician making
multiple temperature measurements in a first room stays connected,
but upon a room change, the first patient context and connection to
the first patient monitor are cleared. For another sensor device,
such as EKG, a rule may be to remove the patient context and
patient monitor connection when the sensor device is removed from
the patient. However, this might cause the patient context to be
lost when EKG electrodes are changed. Additional rules may be added
to the connection profile such as removing patient context from the
sensor device when the distance between the sensor device and
another connected device on the patient is greater than a
predetermined threshold and when a time that the distance is
greater than the predetermined interval is more than a
predetermined time interval. For some workflows, a patient may be
confined to one location, for example a hospital bed, for an
extended period of time. For other workflows, a patient may be
ambulatory and move around their room or a hospital floor. During a
workflow in which a patient is ambulatory, it may be desirable to
monitor the location of the sensor device and to change the patient
monitor device or gateway that receives data from the patient
device to a patient monitor device or gateway that is closer to the
sensor device. As the patient moves around the hospital the ranging
mechanism on the sensor device may determine that the sensor device
is moving out of the range of the patient monitor 208 and is now
closer to a different gateway device. As the sensor device moves
out of the range of the patient monitor 208 and comes into the
range of another gateway device, the sensor device may transmit
sensor data to the gateway device that is now in range. However,
because the sensor device has the patient context, the gateway
device correctly identifies the data as belonging to the
patient.
[0068] When determining which gateway to connect to, the sensor
device may use other metrics in addition to distance. Some examples
of additional metrics include signal strength, noise level on a
floor, interference level, retry rate, the number of devices
already connected to a particular gateway, etc. Other examples are
possible. In addition, the sensor device may be configured to
connect to a specific gateway when multiple gateways are at the
same distance from the sensor device.
[0069] When a determination is made whether to switch gateways, it
may be desirable to determine an absolute location of the sensor
device. In a hospital setting, the location of each fixed gateway
device and patient monitor is typically known. When a sensor device
is moved to be in close proximity with a gateway device, once it is
determined that the sensor device is within close proximity (at a
range, r) of the gateway device, because the location of the
gateway device is known, the location of the sensor device is also
known to be on a sphere of radius r with center at the location of
the gateway. If r is small, perhaps less than 25 cm, it can be
assumed that the sensor and the gateway are co-located. There may
cases where the sensor device is within range of more than one
gateway device. When the sensor device is within range of more than
one gateway, a method of interpolation, for example triangulation,
may be used to determine a more precise location of the sensor
device. For example, if the sensor device is within range of three
gateway devices, the location of each of the three gateway devices
may be considered as a point on a triangle. Using triangulation,
the center of the triangle may be determined and established as the
absolute location of the sensor device. Once the absolute location
of sensors is known, the sensors themselves may be used to
triangulate the location of yet additional sensors.
[0070] Gateways may transmit to back-end server ranges and/or
locations of sensor devices that are connected and sensor devices
that are detected, but not connected, for the purpose of location.
Knowing the location of a sensor device, and hence the location of
the patient permits alarms to be escalated to the closest clinician
and provides alerts if the patient moves out of a designated area.
In addition, knowledge of sensor location permits sensors to be
located when lost and permits alerts if sensors are moved out of a
specific area. When periodic maintenance is required on a group of
devices, a biomedical engineer may query the back-end server for
the last-known location of devices. As a theft deterrent, sensors
may be automatically disabled when the sensor location is not
within certain parameters, such as a particular area of a hospital.
As a second theft deterrent, the sensor may be automatically
disabled except when making an initial connection to a particular
gateway. This would allow the sensor assigned to a particular room
to connect to the gateway in that room, and then roam as the
patient ambulates. However, if the sensor has not made a reading
recently, it will only connect to its particular gateway.
[0071] When communicating status and control information between
the sensor device and gateway device, the radios on the sensor
device and gateway device preferably implement a method to transmit
status and control information and physiological data without
needing to switch operating modes. The method is implemented by via
an application programming interface (API) on the sensor and
gateway devices. Examples of status and control information include
signal strength, current network status, authentication status,
changes to alarm thresholds, charging status, over- and
under-voltage detection, and battery charge level. Other examples
of status and control information are possible.
[0072] Ranging information may also be used to respond to queries.
For example, a sensor device may receive a query when a connection
process is started (i.e., when the sensor device is within a
predetermined distance of another sensor device or the patient
monitor). The query may be issued to indicate that the connection
process has been started and to confirm that the connection process
should be completed. The sensor device may respond to the query by
moving the sensor device closer to or farther away from the other
sensor device or the patient monitor. A movement of the sensor
device toward the other sensor device or patient monitor may be
interpreted as a "yes" and a movement away from the sensor device
or patient monitor may be interpreted as a "no". In other examples,
a "no" may represent movement toward the other sensor device or the
patient monitor and a "yes" may represent movement away from the
other sensor device or the patient monitor.
[0073] Alternatively, an accelerometer may be used to detect motion
corresponding to a "yes" or a "no". For example, movement of the
sensor device up and down may constitute a "yes" and movement of
the sensor device from side to side may constitute a "no". In other
examples, movement of the sensor device up and down may constitute
a "no" and movement side to side may constitute a "yes". Moving the
sensor device slowly may constitute a "no" and moving the sensor
device rapidly may constitute a "yes"
[0074] As another example of the use of ranging motion to respond
to queries, a clinician may use sensor motion to indicate whether a
temperature reading is correct. Sometimes there may be an error in
a temperature reading obtained via a thermometer. Through a certain
motion, per the examples above, a clinician can confirm that the
temperature reading is correct and have the temperature reading
transmitted to an EMR/EHR system or cause the reading to be
deleted.
[0075] Ranging information may be used to detect relative motion
between two medical devices as the range increases or decreases.
Detection of motion can cause a state change of the medical device
and/or the radio. Since ranging requires power, it is advantageous
to minimize use of the ranging function for battery-operated
devices; however, minimizing use of the ranging function may cause
a lag in response time. An adaptive ranging function that
determines range perhaps every 1 second could determine when the
sensor is being moved and then change the ranging rate to every 0.1
seconds, for example, to provide fast response and ability to
detect finer motion. When the ranging function determines the
sensor is within a certain range of another sensor or medical
device, it may cause the radio state to change from discoverable
state to connectable and it may move the radio from a standby
(ranging only) to a fully-on state to allow the connection to be
made. When a first sensor's radio determines it is within a certain
range of a second sensor, an output from the first sensor's radio
may cause the first sensor to move from a standby or off state to a
fully on state. Ranging values may be averaged for higher
accuracy.
[0076] In some embodiments as explained later, the radio on the
sensor device may operate in a low-power mode. In these
embodiments, the proximity detection feature of the radio may be
used to turn on a sensor device when another sensor device, for
example the SPO2 sensor, or gateway comes into close proximity or
when certain criteria are met. For example, the radio may turn on
the sensor device, putting the sensor device in a connectable
state, when a MAC address matches. Other criteria may include
detecting a specific device profile and through action such as an
accelerometer, physical contact and detection of a magnet or a
magnetic field produced by a coil carrying a current. Upon initial
power-up, the radio may go immediately into a first mode to quickly
detect devices and then go into a lower-power mode. In the
lower-power mode, the sensor device may detect other devices or may
be detected by other devices, although not as rapidly as during
initial power-up.
[0077] The API on the sensor and gateway devices also permits
configuration of the radio on the sensor and gateway devices to
configure the radio to sleep and to awaken the radio when a sensor
or gateway device is ready to transmit data. For some sensor
devices, the radio may remain in a sleep mode until an alarm
occurs. The alarm may be related to a proximity detection beacon or
to a wake-up check message requesting status from the radio. When
the alarm occurs, the radio awakens to process the alarm. The API
may also allow configuration to optimize channel robustness vs.
power. For example, in a 54 Mbps channel, 3 Mbps requires the
transmitter to only have a 5.5% duty cycle; however, there may be a
17 dB improvement in receiver sensitivity at 6 Mbps vs. 54
Mbps.
[0078] As noted, the sensor devices used in the PAN are wireless
devices. Because wireless devices are inherently less reliable than
wired devices, the radio on the sensor devices incorporate forward
error correction or other means to recover packets that are
received without transmission errors.
[0079] In example embodiments, the sensor devices in a PAN may all
be in the range of a hub device such as patient monitor 208. In
these embodiments, when one sensor device detects a radio of a
sensor device not already on the PAN, the sensor device
communicates the detection of the sensor device to the other sensor
devices on the PAN and to the patient monitor. As a result, the
patient monitor moves to a state in which detection and connection
can occur rapidly.
[0080] In example embodiments, the ranging capability of the sensor
device may also support a scatternet. A scatternet is a network
that comprises two or more personal area networks, each personal
area network having two or more RF enabled devices. In a
scatternet, at least one of the RF enabled devices is a member of
two PANs, allowing communication between PANs. In a BT scatternet,
this device is a slave in one PAN and a master in another. In a
scatternet, there is an intersection of personal area networks such
that one slave Bluetooth enabled device is part of each of two
intersecting personal area networks. With UWB ranging, RF-enabled
devices in the scatternet may connect to each other securely using
range-based authentication.
[0081] FIG. 3 show an example patient monitor 300. The example
patient monitor 300 is a portable device and includes two example
proximity detectors 308 and 310. The proximity detectors 308 and
310 are mounted internally in the patient monitor 300 with one
surface of each of proximity detectors 308 and 310 being adjacent
to an external surface of the patient monitor 300.
[0082] Also shown in FIG. 3 are two example physiological sensor
devices 304, 306, each including a proximity detector, possibly
disposed as part of the radio. Physiological sensor devices 304,
306 are both proximal to the proximity detector 308 disposed in
patient monitor 302 and may both join the patient monitor PAN using
range-based authentication. In examples, more or fewer proximity
detectors may be used and the proximity detectors may be located on
different areas of the patient monitor 300, or as an external
device, perhaps connected via USB to the patient monitor.
[0083] FIG. 4 shows an example physical view for the proximity
detection mechanism for physiological sensor 110 and proximity
detector 202 that is separate from the radio. Physiological sensor
110 is housed in a plastic housing 402 and includes a printed
circuit board (PCB) 404 that includes sensor electronics 204 and
Bluetooth radio 206 (not shown), a magnet 408 and a magnetic
detector 406. The magnet 408 and magnetic detector 406 comprise
proximity detector 202. Patient monitor 208 is housed in a plastic
housing 410 and includes a printed circuit board 412, a magnet 416
and a magnetic detector 414. The magnet 416 and magnetic detector
414 comprise proximity detector 210. Patient monitor 208 includes
the Bluetooth radio 216 (not shown). When physiological sensor 110
is moved into close proximity with patient monitor 208, magnet 408
on physiological sensor 110 activates magnetic detector 414 in
patient monitor 208 and magnet 416 on patient monitor 208 activates
magnetic detector 406 on physiological sensor 110.
[0084] The magnetic detectors 406, 414 are typically a magnetic
switch such as a reed switch, a reed relay, a Hall Effect sensor, a
Hall Effect switch or a giant magnetoresistance (GMR) detector.
These magnetic switches permit proximity detection using very low
power.
[0085] The reed switch is a normally open switch, thereby drawing
little or no power in the open state. The reed switch closes when a
magnetic field of a predetermined threshold is detected by the reed
switch. A typical threshold for a sensitive reed switch may vary
between 5 Ampere-Turns and 15 Ampere-Turns. However, this assumes a
uniform magnetic field along the axis of the axially leaded
part.
[0086] A Hall effect sensor generates a voltage in response to a
magnetic field. The generated voltage increases as the magnetic
field increases. For example, when a magnet is moved in the
proximity of the Hall effect sensor, the magnetic field of the
magnet cutting through the sensor increases as the magnet is moved
closer to the Hall effect sensor. The Hall effect sensor may be
combined with circuitry such as a comparator that permits the Hall
effect sensor to act as a switch. When the magnetic field reaches a
predetermined threshold, a magnetic switch closes, signifying an
"on" state. A sensitive Hall effect sensor may operate at field
strengths of around 10 to 25 Gauss, depending on temperature and
frequency of the magnetic field.
[0087] A GMR switch includes giant magnetoresistance material and
makes use of the concept of magnetoresistance. With
magnetoresistance the electrical resistance of the GMR material
changes its value when a magnetic field is applied to it. When the
magnetic field reaches a predetermined threshold, the resistance of
the GMR material is changed to a point such that sufficient current
flows through a bridge in the GMR switch to close the GMR switch,
signifying an "on" state. Some GMR switches, for example GMR
switches in the AFL200 series from NVE Corporation, require only a
few microamperes of supply current. A sensitive GMR switch may
operate at a field strength of 7-13 Gauss.
[0088] Whether the magnetic switch is normally open or normally
closed is not relevant to the detection of an applied magnetic
field; rather only the state change is important.
[0089] Magnetic flux densities decrease in strength exponentially
with increasing distance from the source of the magnetic field, for
example a magnet. The magnet 408 must be strong enough to activate
magnetic detector 414 when physiological sensor 110 is brought in
the proximity of the magnetic detector 414. However, at the same
time, the magnet 408 must be positioned so that the magnet 408 does
not falsely trigger magnetic detector 406 or any other magnetic
detectors in other medical devices that may be implanted on a
patient. For example, implantable cardio defibrillators may have
embedded magnetic detectors that are typically activated at a field
strength of greater than 10 Gauss. However, in order to create a
magnetic field that is reliably detectable by magnetic detector on
a patient monitor 208, magnet 408 and magnet 416 may need to
provide a magnetic field or more than 10 Gauss.
[0090] Each magnet 408, 416 is located on the outside of their
respective plastic housing 402, 410. Each magnet 408, 416 is
recessed in the plastic housing 402 and positioned so that one side
of each magnet 408, 416 is flush with a side of the plastic housing
402. The reason magnets 408 and 416 are located on the outside on
their respective plastic housing 402, 410 is to permit the use of a
weaker magnet than would be needed if the magnets 408 and 416 were
located within their plastic housing. The reason for this is the
exponential decrease in magnetic flux density with distance.
Suppose a magnet were placed on the inside of the plastic and had
sufficient magnetization to create a field of 10 Gauss at 4 mm
outside the plastic. Comparing to a magnet recessed as indicated by
magnets 408 and 416 that has sufficient magnetization to create a
field of 10 Gauss at 4 mm from the outside of the plastic, the
latter magnet would be weaker and its field strength at more than 4
mm from the outside of the plastic will be less than the field
strength of the stronger magnet placed inside of the plastic.
[0091] Using a weaker magnet minimizes the risk of false triggers
for medical devices that contain embedded magnetic detectors.
Placing magnets 408 and 416 on the outside of their respective
plastic housings places magnet 408 closer to magnetic detector 414
than would be the case if magnet 408 were located inside of plastic
housing 402 and places magnet 416 closer to magnetic detector 406
than would be the case if magnet 416 were located inside of plastic
housing 410. Typically, the spacing gap between magnets 416 and
magnetic detector 406 and between magnet 408 and magnetic detector
414 is reduced by 2 millimeters by placing magnets 408 and 416 on
the outside of their respective plastic housings.
[0092] Physical detents may be included in the plastic housing to
help the user properly locate the sensor 110 relative to patient
monitor 208 to trigger the proximity detection. Labels may be used
over the magnets 408 and 416 and over the magnetic detectors 406
and 408 to help guide the user to place the physiological sensor
110 in proper alignment with the magnetic detector in monitor
208.
[0093] FIGS. 5 and 6 show a flowchart 500 for a method for using
proximity detection to establish a connection between a sensor
device, for example physiological sensor 110 and a gateway device,
for example patient monitor 208. At operation 502, a radio on the
sensor device is in a non-connectable state. Typically, both the
radio and the sensor device are powered off. An internal retry
count is set to zero.
[0094] At operation 504, a determination is made whether a
proximity detector on the sensor device is activated. The proximity
detector on the sensor device is typically not activated until the
sensor device is proximal to the gateway device. The determination
of whether the proximity detector is activated comprises whether a
magnet, for example magnet 416 on the gateway device activates a
magnetic detector, for example magnetic detector 406 on the sensor
device. Depending on the strength of the magnet on the gateway
device, the sensor device may need to be moved within centimeters
of the gateway device or in some examples the sensor device may
need to physically touch the gateway device in order for the
magnetic detector to be activated.
[0095] When a determination is made at operation 504 that the
proximity detector is not activated, control loops back to
operation 502. Control loops between operation 502 and operation
504 until the proximity detector is activated.
[0096] When a determination is made at operation 504 that the
proximity detector is activated, at operation 508, the Bluetooth
radio on the sensor device is set to a connectable state, in
low-power. This includes powering on the radio if it was not
powered. The use of low-power radio transmission during connection
improves security during the connection process, but is not
required.
[0097] At operation 510, a determination is made as to whether the
sensor device detects a second radio device, for example a
Bluetooth radio, on the gateway device and whether the gateway
device detects a radio device on the sensor device. Typically,
proximity detection occurs near simultaneously at sensor device and
the gateway device and each places its respective radio in a
connectable state. This connectable state may include also being
discoverable. However, the Bluetooth radio on the gateway device
may turn on at a slightly different time than the Bluetooth radio
on the sensor device. It is also possible that one magnetic
detector was triggered and the other was not. If the out-of-band
proximity detection transmits the MAC address, discovery times may
be significantly decreased compared to methods such as paging.
[0098] If a determination is made at operation 510 that a second
Bluetooth radio is not detected, typically because there is a
slight delay in turning on power for the second Bluetooth radio, at
operation 510 a retry count is incremented. At operation 512, a
determination is made as to whether a retry limit has been reached.
When it is determined at operation 512, that a retry limit has not
been reached, control returns to operation 508 and another
determination is made as to whether a second Bluetooth radio has
been detected. When it is determined at operation 512, that a retry
limit has been reached, control returns to operation 502 and the
sensor device is put back in a non-connectable state.
Alternatively, instead of a fixed number of retries, a
determination may be made at operation 512 as to whether a timeout
limit has been reached.
[0099] When a determination is made at operation 510 that a second
Bluetooth radio has been detected, at operation 516, Bluetooth
pairing is performed between the sensor device and the gateway
device.
[0100] At operation 518, the radio devices are set to a standard
power level and the sensor device is paired to the gateway device.
For example, standard power is 4 dBm for a Class II Bluetooth radio
and 20 dBm for a Class I Bluetooth radio.
[0101] At operation 520, status and configuration information are
transferred between the sensor device and the gateway device. The
status and configuration includes such items as the strength of a
battery on the sensor device and the model and version numbers of
the sensor device and the gateway device. The status and
configuration information are transferred in an attempt to
determine whether the sensor device is operationally compatible
with the gateway device.
[0102] At operation 522, a determination is made as to whether the
sensor device and the gateway device are compatible. The
determination is made by comparing the model number and version of
the sensor device with the model number and version number of the
gateway device to a file or database indicating the set of
compatible versions and models.
[0103] When it is determined at operation 522 that the sensor
device and the gateway device are not compatible, at operation 524,
a status message that the sensor device and gateway device are not
compatible is displayed to the user. This status message might be
displayed on the gateway device, the sensor device, a syslog
server, through e-mail or other electronic communication. At
operation 526, the logical connection between the sensor device and
the gateway device is broken and the connection sequence ends.
Breaking the logical connection might be at the application layer
or at the RF layer and might include removing stored pairing
information. The incompatibility message may be sent to a server.
Alternately, the user may be prompted to confirm download of new
software that corrects an incompatibility option before destroying
the radio connection.
[0104] When it is determined at operation 522 that the sensor
device and the gateway device are compatible, at operation 528, a
message that the sensor device and the gateway device are
compatible is displayed on the user interface of the gateway device
and the clinician is prompted to confirm the patient for the sensor
device. The confirmation of the patient to the sensor device
provides an additional level of security to ensure that the sensor
device is being assigned to the correct patient.
[0105] If there is no confirmation determined at operation 528, at
operation 530, a determination is made as to whether the allotted
wait time for the clinician has expired. If a timeout occurs,
meaning that the clinician has not confirmed the patient for the
sensor device within a reasonable period of time, at operation 524,
a message is displayed on the user interface of the gateway device
that the patient has not been confirmed for the sensor and at
operation 526, the logical connection between the sensor device and
the gateway device is broken. At operation 530, if the timeout
limit has not been reached, then control is returned to operation
528.
[0106] When the patient has been confirmed for the sensor device,
at operation 532, the connection mode is selected. As discussed,
the connection mode can be one of loose pairing, tight pairing or
locked. Additional connection modes may be created to support
additional clinical work flows.
[0107] FIG. 7 shows a flowchart for a method of transferring
patient context to a first sensor device, for example to SPO2
sensor device 110. At operation 702, sensor device 110 is moved
within range of a second sensor device, for example sensor device
108. As sensor device 110 is moved within range with sensor device
108, sensor device 110 sends out ranging signals to sensor device
108. The ranging signals are generated from UWB circuitry in a
proximity detector on sensor device 108. It should be noted that
the second sensor device may be a patient monitor.
[0108] At operation 704, a determination is made as to whether the
distance between sensor device 110 and sensor device 108 is within
a predetermined distance threshold. The distance threshold is a
small distance, typically less than 25 cm, which provides an
indication that sensor device 110 is in close proximity with sensor
device 108. When the distance between sensor device 110 and sensor
device 108 is less than the predetermined threshold, at operation
706 sensor device 110 is authenticated on a personal area network
that includes sensor device 108. The authentication comprises
sensor device 110 sending an identifier to sensor device 108. The
identifier, typically a MAC address of sensor 110, is received by
sensor device 108 and sent from sensor device 108 to a patient
monitoring device, for example patient monitor 108. Patient monitor
108 sends the MAC address via a gateway, for example LAN/WAN
gateway 218, to an EMR/EHR system. The EMR/EHR system authenticates
the MAC address. When a sensor device does not have enough memory
to store a MAC address, a serial number for the sensor device may
be used as an identifier instead of the MAC address.
[0109] At operation 708, when sensor device 110 is authenticated,
at operation 710 a determination is made as to whether the sensor
device 110 should join the PAN. The determination as to whether
sensor device 110 should join the PAN is typically based on
multiple factors. One factor may be the distance between sensor
device 110 and sensor device 108. A second factor may be the time
interval that the distance between sensor device 110 and sensor
device 108 is within the predetermined threshold. A third factor
may be whether a physiological measurement has been made from
sensor device 110. Other factors may be considered.
[0110] At operation 712, when a determination is made that sensor
device 110 should join the PAN, at operation 714, patient context
is obtained and stored on sensor device 110. The patient context,
typically an identifier for the patient, is obtained from patient
monitor 208 or from the EMR/EHR system via gateway 218. At
operation 716, when physiological data is sent from sensor device
110 to patient monitor 208, the patient context is sent along with
the physiological data. Sending patient context along with the
physiological data helps ensure that the physiological data is
identified as being associated with the correct patient and allows
the sensor to upload data to any gateway, as would be useful for
ambulatory patients.
[0111] FIGS. 8 and 9 show a flowchart 800 for a method for using
UWB ranging to establish a connection between a sensor device, for
example physiological sensor 110 and a gateway device, for example
patient monitor 208. At operation 802, a radio on the sensor device
begins low rate ranging. In examples, for low rate ranging, the
radio on the sensor device may send out ranging signals at a rate
between one ranging signal every second to one ranging signal every
30 seconds. In other examples, different rates may be used for low
rate ranging. In examples, the ranging signal may comprise more
than one signal. Low rate ranging is typically used when it is
unknown how far the sensor is from the gateway device. In this
situation, low rate ranging may be used to conserve battery
power.
[0112] At operation 804, a determination is made as to whether the
gateway device is within a first range of the sensor device. In
examples, the first range of the sensor device may be a distance of
5 meters. Other values for the first range may be used.
[0113] When it is determined at operation 804 that the first sensor
device is not within the first range, control returns to operation
804 and another check on the first range is made. When it is
determined at operation 804 that the first sensor device is within
the first range, at operation 808, the radio on the sensor device
begins high rate ranging. High rate ranging comprises sending out
ranging signals at a higher frequency than for low rate ranging. In
examples, high rate ranging may comprise sending out one or more
ranging signals every 0.05 to 0.5 seconds. Other frequencies of
high rate ranging may be used.
[0114] At operation 810 a determination is made as to whether the
gateway device is within a second range of the sensor device. The
second range is a smaller value than the first range, corresponding
to a predetermined distance threshold, as discussed earlier herein.
In examples, the second range may be a distance of 50 cm. Other
values for the second range may be used.
[0115] When a determination is made at operation 810 that the
gateway device is not within the second range of the sensor device,
at operation 812 a determination is made as to whether a retry
limit or timeout has been reached. When a determination is made at
operation 812 that a retry limit or timeout has been reached, at
operation 806, the first range is adjusted to a lower value. In
examples, the first range may be reduced by 50 percent. In other
examples, the first range may be reduced by a different amount. One
reason for reducing the first range at operation 806 is to reduce
the amount of time that the sensor may be in a high range mode,
thereby conserving battery power on the sensor. Control then
returns to operation 802, returning the sensor to low rate ranging.
If a determination is made at operation 812 that neither a retry
limit nor timeout has been reached, control is returned to
operation 810.
[0116] When a determination is made at operation 810 that the
sensor device is within the second range, at operation 816,
range-based authentication and pairing is performed between the
sensor device and the gateway device.
[0117] At operation 818, the first range is reset, typically to a
default value. The first range is reset because the first range may
have been changed at operation 806. At operation 819, the sensor
device begins low rate ranging.
[0118] At operation 820, status and configuration information are
transferred between the sensor device and the gateway device. The
status and configuration includes such items as the strength of a
battery on the sensor device and the model and version numbers of
the sensor device and the gateway device. The status and
configuration information are transferred in an attempt to
determine whether the sensor device is operationally compatible
with the gateway device.
[0119] At operation 822, a determination is made as to whether the
sensor device and the gateway device are compatible. The
determination is made by comparing the model number and version of
the sensor device with the model number and version number of the
gateway device to a file or database indicating the set of
compatible versions and models.
[0120] When it is determined at operation 822 that the sensor
device and the gateway device are not compatible, at operation 824,
a status message that the sensor device and gateway device are not
compatible is displayed to the user. This status message might be
displayed on the gateway device, the sensor device, a syslog
server, through e-mail or other electronic communication. At
operation 826, the logical connection between the sensor device and
the gateway device is broken and the connection sequence ends.
Breaking the logical connection might be at the application layer
or at the RF layer and might include removing stored pairing
information. The incompatibility message may be sent to a server.
Alternately, the user may be prompted to confirm download of new
software that corrects an incompatibility option before destroying
the radio connection.
[0121] When it is determined at operation 822 that the sensor
device and the gateway device are compatible, at operation 828, a
message that the sensor device and the gateway device are
compatible is displayed on the user interface of the gateway device
and the clinician is prompted to confirm the patient for the sensor
device. In addition, the gateway device transfers patient context
to the sensor device. The confirmation of the patient to the sensor
device provides an additional level of security to ensure that the
sensor device is being assigned to the correct patient. In some
conditions when it is there is no ambiguity as to whether the
patient should be confirmed for the sensor, the system may
automatically confirm the patient for the sensor and transfer the
PID.
[0122] If there is no confirmation determined at operation 828, at
operation 830, a determination is made as to whether the allotted
wait time for the clinician has expired. If a timeout occurs,
meaning that the clinician has not confirmed the patient for the
sensor device within a reasonable period of time, at operation 824,
a message is displayed on the user interface of the gateway device
that the patient has not been confirmed for the sensor and at
operation 826, the logical connection between the sensor device and
the gateway device is broken. At operation 830, if the timeout
limit has not been reached, then control is returned to operation
828.
[0123] When the patient has been confirmed for the sensor device,
at operation 832, the connection mode is selected. As discussed,
the connection mode can be one of loose pairing, tight pairing or
locked. Additional connection modes may be created to support
additional clinical work flows.
[0124] A physiological sensor and monitor that incorporate
Bluetooth technology are computing devices and typically include at
least one processing unit, system memory and a power source.
Depending on the exact configuration and type of computing device,
the system memory may be physical memory, such as volatile memory
(such as RAM), non-volatile memory (such as ROM, flash memory,
etc.) or some combination of the two. System memory typically
includes an embedded operating system suitable for controlling the
operation of the sensor device. The system memory may also include
one or more software applications, for example Bluetooth, and may
include program data.
[0125] The various embodiments described above are provided by way
of illustration only and should not be construed to limiting.
Various modifications and changes that may be made to the
embodiments described above without departing from the true spirit
and scope of the disclosure.
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